Class 1 Device Recall TurboHawk Plus

• Date Initiated by Firm: February 04, 2022
• Date Posted: March 07, 2022
• Recall Status: Terminated on October 02, 2024
• Recall Number: Z-0694-2022
• Recall Event ID: 89470
• 510(K)Number: K212027
• Product Classification: Catheter, peripheral, atherectomy - Product Code MCW
• Product: Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
• Code Information: GTIN 00763000402396
• Recalling Firm/ Manufacturer: ev3 Inc.; 4600 Nathan Ln N; Plymouth MN 55442-2890
• For Additional Information Contact: Medtronic Customer Service; 800-854-3570
• Manufacturer Reason for Recall: The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
• FDA Determined Cause: Labeling design
• Action: The recalling firm began issuing the URGENT MEDICAL DEVICE NOTICE dated February 2022 on 2/4/2022 via 2-day UPS delivery. The letter explained the issue and instructed the consignee to adhere to the existing IFU instructions and warnings and precautions listed in the letter to reduce the risk of guidewire prolapse. The Customer Instructions included the notice was to be shared with all who needed to be aware within the consignee's organization or to any other organization where the product has been transferred; to review the IFU included with the product prior to use, noting the warnings and precautions listed in the notice; and to complete the Customer Confirmation Form to acknowledge receipt of the notice and that the appropriate action has been taken. It was to be emailed to the recalling firm.
• Quantity in Commerce: 441 devices
• Distribution: US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MCW